Ignite Creation Date:
2024-05-06 @ 6:19 PM
Last Modification Date:
2024-10-26 @ 2:46 PM
Study NCT ID:
NCT05628025
Status:
COMPLETED
Last Update Posted:
2022-11-28
First Post:
2021-09-13
Brief Title:
Simulation-Based Enucleation Training Initial Experience Using 3D-printed Organ Phantoms
Sponsor:
Centre hospitalier de lUniversité de Montréal CHUM
Organization:
Centre hospitalier de lUniversité de Montréal CHUM
Study Overview
Official Title:
Simulation-Based Enucleation Training Initial Experience Using 3D-printed Organ Phantoms
Status:
COMPLETED
Status Verified Date:
2022-11
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
There are many possible surgical treatments when a patient presents with lower urinary tract symptoms due to an enlarged prostate termed benign prostatic hyperplasia or BPH One technique consists of using a laser to remove prostatic tissue through the penis called laser enucleation of the prostate or LEP LEP also has excellent properties to reduce blood loss and results in shorter hospital stays Trainees must observe and perform several procedures before mastering the LEP technique Different models have been used to mimic the LEP experience for surgeon trainees such as virtual simulators or synthetic models While these simulators offer an alternative to LEP procedures on real patients they may lack realism which renders the simulator less representative than the real procedureThe 3D-printed prostate model of the present study mimics the properties of real-life prostatic tissue In the setting of the MasterClass trainees will perform LEP on the 3D models under the supervision of three experts While the 3D organ phantom has been used to practice performing other procedures this is the first time it will evaluated for LEP training For this reason the investigators will be assessing this model as a training tool
Detailed Description:
Numerous surgical treatment options exist for benign prostatic hyperplasia BPH Laser enucleation of the prostate LEP was introduced in the therapeutic arsenal about twenty years ago and has become a popular treatment due to its excellent hemostatic properties Moreover LEP is associated with less blood loss and shorter hospital stays One disadvantage however may be the longer learning curve for trainees compared to transurethral resection of the prostate TURP which is the current gold standard for treatment
It is estimated that a surgeon can safely and efficiently perform holmium LEP after about 50 cases Simulator-based training has been widely proposed as a training tool for surgeons to learn LEP Integrating simulators in surgical training allows surgeons to develop skills in LEP without negative consequences on real patients Simulators range from virtual reality to synthetic bench models and all face the same challenge of creating a realistic experience that accurately mimics real-life LEP and helps surgeons develop skills they can transfer to the operating room
The prostate organ phantom in the present study is composed of hydrogels and uses 3D molds to recreate prostatic tissue and anatomy This model has successfully been used to practice TURP procedures however has not yet been validated for LEP training This observational prospective and comparative study aims to validate the 3D prostate organ for LEP training In the setting of a MasterClass trainees will perform LEP on two 3D models under the supervision of three experts in LEP The content and face validity of the organ phantoms will be evaluated by the MasterClass participants through a questionnaire Performance outcomes of trainees will also be collected by visually examining the models and weighing the models pre- and post-operatively By validating this simulator for LEP training the investigators hope to elucidate the role of simulators and specifically the role of a 3D organ phantom in future training programs
It is estimated that a surgeon can safely and efficiently perform holmium LEP after about 50 cases Simulator-based training has been widely proposed as a training tool for surgeons to learn LEP Integrating simulators in surgical training allows surgeons to develop skills in LEP without negative consequences on real patients Simulators range from virtual reality to synthetic bench models and all face the same challenge of creating a realistic experience that accurately mimics real-life LEP and helps surgeons develop skills they can transfer to the operating room
The prostate organ phantom in the present study is composed of hydrogels and uses 3D molds to recreate prostatic tissue and anatomy This model has successfully been used to practice TURP procedures however has not yet been validated for LEP training This observational prospective and comparative study aims to validate the 3D prostate organ for LEP training In the setting of a MasterClass trainees will perform LEP on two 3D models under the supervision of three experts in LEP The content and face validity of the organ phantoms will be evaluated by the MasterClass participants through a questionnaire Performance outcomes of trainees will also be collected by visually examining the models and weighing the models pre- and post-operatively By validating this simulator for LEP training the investigators hope to elucidate the role of simulators and specifically the role of a 3D organ phantom in future training programs
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None